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Pharmaceutical Pack Management - why is it important?

Pharma Pack Management, artwork administration, artwork
co-ordination…..whichever description you use, managing pharmaceutical
labelling artwork is a pivotal function in the pharmaceutical supply chain and
one that rarely gets the attention it deserves.

Performed effectively, implementing and maintaining
compliant labelling for product SKUs (stock keeping units) becomes an
opportunity to reduce costs, improve an organisation’s reputation for quality and differentiate them from their competitors.

But perform it badly or not at all, it can harm your
patients, kill your company, trigger a product recall, delay product supply or
regularly cause stock outs that directly impact the balance sheet. When errors
occur, 4 main groups are impacted;

Patients

Effective medical treatment is based on
trust at all levels. Patients put their trust in a health professional directly
through consultation and prescription. They also place their trust in
pharmaceutical companies to produce and supply them a prescribed product to the
highest standards of quality and this includes the labelling. An error in the
labelling can therefore not only be directly harmful – by causing a prescribing
error for instance – but can also undermine the confidence a patient population
has in individual drug companies.

Prescribers

There is an expectation held by all
prescribers, be they pharmacists, consultants, doctors, nurses or other health
care professionals that products and their labelling will be accurate, up to
date, free from errors and manufactured to the highest quality standards. Aside
from a prescribers trust in a company and product being damaged by labelling
errors, they are also directly impacted as remedial action on their part
diverts resources away from their primary function of providing health care
services.

Regulators

With labelling errors identified as a
significant cause of recalls, regulators are increasingly focusing audit
attention on labelling change processes. With today’s technological advances
providing opportunities for improved quality they are becoming less tolerant of
bad practice and have the powers to take punitive action against companies not
meeting expected GMP standards.

Pharmaceutical
companies

At a macro level, pharmaceutical companies
can be significantly harmed, both in terms of reputation and share price, by
labelling errors. These indirect costs are joined by the direct costs of
managing an incident. Reworking or batch and product write-offs often result,
which alone can run into costs of tens of thousands. Drilling down further, the
affected artwork studios and process participants will be analysing causes for
the error and looking for ways to improve the process.

With its importance better understood our next article will
focus on where to locate the pack management department in a pharma business.